Implant TherapyMohamed sedkyNCT07569146
Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone.
A study testing Immediate dental implants with bone graft augmentation (deproteinized bovine bone) and Immediate dental implants without bone augmentation in people with Implant Therapy, run by Suez Canal University at 1 site in Egypt.
Trial summary
: Many of studies have been performed to improve osseointegration and bone density around implants by modifying the implant by adding bone graft or substitute material that increase success of implant. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Therapy
- What is being tested?
- Immediate dental implants with bone graft augmentation (deproteinized bovine bone) and Immediate dental implants without bone augmentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 8 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with hopeless teeth at maxillary esthetic zone.
- Both genders.
- Middle age adults (from 20 years to 55 years).
- The tooth to be extracted had little to no loss of periodontal bone.
- The tooth where endodontic involvement, root fracture, root resorption, periapical pathology, root perforation
Who cannot join
- 1-Medically compromised patient (uncontrolled diabetes, radiotherapy, chemotherapy and hemophilia.
- 2-Patient with bad oral habit as bruxism, heavy smoking over 10 cigarettes a day.
- 3-Patient with bad oral hygiene. 4-Patient with generalized gingival diseases. 5-Patient with generalized periodontal diseases [with sever vertical or horizontal bone loss] 6-Teeth with periapical or lateral acute infection or lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone: A Randomized Clinical Study
: Many of studies have been performed to improve osseointegration and bone density around implants by modifying the implant by adding bone graft or substitute material that increase success of implant. Aim: The aim of this study is to evaluate clinically the efficacy of deproteinized bovine bone in maxillary Esthetic zone to promote bone formation and improve outcomes in immediate implant cases. Methodology: 16 immediate implants will be placed in maxillary esthetic zone. That study will be Conducted on 16 hopeless teeth divided equally and randomly into two groups Randomization will be done using www.randomizer.org ., Group 1: 8 hopeless teeth will be replaced by immediate dental implants represent the (control group) where the implants will be placed without bone graft, Group 2: 8 hopeless teeth will be replaced by immediate dental implants represent the (study group) where the implants will be placed with deproteinized bovine bone graft. The implant stability will be assessed clinically using (Ostell) immediate postoperative and after 6 months and Postoperative pain using visual analogue scale (VAS)
Read the detailed description
: Many of studies have been performed to improve osseointegration and bone density around implants by modifying the implant by adding bone graft or substitute material that increase success of implant. Aim: The aim of this study is to evaluate clinically the efficacy of deproteinized bovine bone in maxillary Esthetic zone to promote bone formation and improve outcomes in immediate implant cases. Methodology: 16 immediate implants will be placed in maxillary esthetic zone. That study will be Conducted on 16 hopeless teeth divided equally and randomly into two groups Randomization will be done using www.randomizer.org ., Group 1: 8 hopeless teeth will be replaced by immediate dental implants represent the (control group) where the implants will be placed without bone graft, Group 2: 8 hopeless teeth will be replaced by immediate dental implants represent the (study group) where the implants will be placed with deproteinized bovine bone graft. The implant stability will be assessed clinically using (Ostell) immediate postoperative and after 6 months and Postoperative pain using visual analogue scale (VAS). Pre and Post Operative CBCT Will be taken. Bone density will be assessed Using 3D onDemand Softwear.
- Conditions
- Implant Therapy
- Being tested
- Immediate dental implants with bone graft augmentation (deproteinized bovine bone), Immediate dental implants without bone augmentation
- Keywords
- deproteinized bovine bone, Implant, clinical stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate dental implants with bone graft augmentation (deproteinized bovine bone)Device
8 hopeless teeth was replaced by immediate dental implants with deproteinized bovine bone graft.
Immediate dental implants without bone augmentationDevice
8 hopeless teeth was replaced by immediate dental implants without bone augmentation
| Study group | Role | What they receive |
|---|---|---|
| Study group : immediate implants placement with deproteinized bovine bone augmentation | Active comparator | 8 hopeless teeth was replaced by immediate dental implants with deproteinized bovine bone augmentation Receives: Device: Immediate dental implants with bone graft augmentation (deproteinized bovine bone) |
| Control group : Implant implants Placement without bone augmentation | Active comparator | 8 hopeless teeth was replaced by immediate dental implants without bone augmentation Receives: Device: Immediate dental implants without bone augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain (Visual Analog Scale, VAS)
Patients reported the degree of pain using a 10-cm visual analog scale (VAS), where 0 = no pain and 10 = worst possible pain. Pain was assessed at 1, 3, and 7 days postoperatively.
Measured: 1, 3, and 7 days postoperatively
Visual Scale of Edema
Facial edema was assessed using a visual grading scale: No edema, Low-grade, Intermediate-grade, and High-grade, based on visual inspection and palpation. Edema was evaluated at 1, 3, and 7 days postoperatively.
Measured: 1, 3, and 7 days postoperatively
Implant Stability (ISQ)
Clinical stability of dental implants was assessed using the Osstell device. The implant stability quotient (ISQ) was measured immediately after implant placement and at 6 months postoperatively. ISQ scores range from 1-100, with scores ≥70 indicating high stability, 60-69 medium stability, and <60 low stability.
Measured: Baseline (immediately after implant placement) and 6 months postoperatively
Peri-implant Bone Density
Bone density around the implants was measured using CBCT radiographs and analyzed with 3D OnDemand software. Measurements were recorded immediately postoperatively and at 6 months.
Measured: Baseline (immediately after implant placement) and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jan 2025
- Primary completion5 Dec 2025
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant TherapyStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be conducted on 16 hopeless teeth, divided into 2 group Group 1 (Control Group): 8 hopeless teeth will be replaced by immediate dental implants where the implants will be placed without bone graft . Group 2 (Study Group): 8 hopeless teeth will be replaced by immediate dental implants were the implants will be placed with deproteinized bovine bone graft.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569146
- Sponsor's protocol ID
- 969/2025
- Acronym
- Mohamed sedky
- Status last verified
- Apr 2026
- First submitted
- 23 Nov 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Deproteinized Bovine Bone for Immediate Implants Placement in Maxillary Esthetic Zone: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07569146
- Acronym / sponsor ID
- Mohamed sedky / 969/2025
- Conditions
- Implant Therapy
- Keywords
- deproteinized bovine bone, Implant, clinical stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: Many of studies have been performed to improve osseointegration and bone density around implants by modifying the implant by adding bone graft or substitute material that increase success of implant. Aim: The aim of this study is to evaluate clinically the efficacy of deproteinized bovine bone in maxillary Esthetic zone to promote bone formation and improve outcomes in immediate implant cases. Methodology: 16 immediate implants will be placed in maxillary esthetic zone. That study will be Conducted on 16 hopeless teeth divided equally and randomly into two groups Randomization will be done using www.randomizer.org ., Group 1: 8 hopeless teeth will be replaced by immediate dental implants represent the (control group) where the implants will be placed without bone graft, Group 2: 8 hopeless teeth will be replaced by immediate dental implants represent the (study group) where the implants will be placed with deproteinized bovine bone graft. The implant stability will be assessed clinically using (Ostell) immediate postoperative and after 6 months and Postoperative pain using visual analogue scale (VAS)
Detailed description
: Many of studies have been performed to improve osseointegration and bone density around implants by modifying the implant by adding bone graft or substitute material that increase success of implant. Aim: The aim of this study is to evaluate clinically the efficacy of deproteinized bovine bone in maxillary Esthetic zone to promote bone formation and improve outcomes in immediate implant cases. Methodology: 16 immediate implants will be placed in maxillary esthetic zone. That study will be Conducted on 16 hopeless teeth divided equally and randomly into two groups Randomization will be done using www.randomizer.org ., Group 1: 8 hopeless teeth will be replaced by immediate dental implants represent the (control group) where the implants will be placed without bone graft, Group 2: 8 hopeless teeth will be replaced by immediate dental implants represent the (study group) where the implants will be placed with deproteinized bovine bone graft. The implant stability will be assessed clinically using (Ostell) immediate postoperative and after 6 months and Postoperative pain using visual analogue scale (VAS). Pre and Post Operative CBCT Will be taken. Bone density will be assessed Using 3D onDemand Softwear.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be conducted on 16 hopeless teeth, divided into 2 group Group 1 (Control Group): 8 hopeless teeth will be replaced by immediate dental implants where the implants will be placed without bone graft . Group 2 (Study Group): 8 hopeless teeth will be replaced by immediate dental implants were the implants will be placed with deproteinized bovine bone graft.
| Arm | Type | Receives |
|---|---|---|
| Study group : immediate implants placement with deproteinized bovine bone augmentation | Active comparator | Device: Immediate dental implants with bone graft augmentation (deproteinized bovine bone)8 hopeless teeth was replaced by immediate dental implants with deproteinized bovine bone augmentation |
| Control group : Implant implants Placement without bone augmentation | Active comparator | Device: Immediate dental implants without bone augmentation8 hopeless teeth was replaced by immediate dental implants without bone augmentation |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with hopeless teeth at maxillary esthetic zone.
- Both genders.
- Middle age adults (from 20 years to 55 years).
- The tooth to be extracted had little to no loss of periodontal bone.
- The tooth where endodontic involvement, root fracture, root resorption, periapical pathology, root perforation
Key exclusion criteria (3 listed)
- 1-Medically compromised patient (uncontrolled diabetes, radiotherapy, chemotherapy and hemophilia.
- 2-Patient with bad oral habit as bruxism, heavy smoking over 10 cigarettes a day.
- 3-Patient with bad oral hygiene. 4-Patient with generalized gingival diseases. 5-Patient with generalized periodontal diseases [with sever vertical or horizontal bone loss] 6-Teeth with periapical or lateral acute infection or lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate dental implants with bone graft augmentation (deproteinized bovine bone)8 hopeless teeth was replaced by immediate dental implants with deproteinized bovine bone graft. | Device | Study group : immediate implants placement with deproteinized bovine bone augmentation |
| Immediate dental implants without bone augmentation8 hopeless teeth was replaced by immediate dental implants without bone augmentation | Device | Control group : Implant implants Placement without bone augmentation |
Primary outcome
Postoperative Pain (Visual Analog Scale, VAS)
Time frame: 1, 3, and 7 days postoperatively
Patients reported the degree of pain using a 10-cm visual analog scale (VAS), where 0 = no pain and 10 = worst possible pain. Pain was assessed at 1, 3, and 7 days postoperatively.
Visual Scale of Edema
Time frame: 1, 3, and 7 days postoperatively
Facial edema was assessed using a visual grading scale: No edema, Low-grade, Intermediate-grade, and High-grade, based on visual inspection and palpation. Edema was evaluated at 1, 3, and 7 days postoperatively.
Implant Stability (ISQ)
Time frame: Baseline (immediately after implant placement) and 6 months postoperatively
Clinical stability of dental implants was assessed using the Osstell device. The implant stability quotient (ISQ) was measured immediately after implant placement and at 6 months postoperatively. ISQ scores range from 1-100, with scores ≥70 indicating high stability, 60-69 medium stability, and <60 low stability.
Peri-implant Bone Density
Time frame: Baseline (immediately after implant placement) and 6 months postoperatively
Bone density around the implants was measured using CBCT radiographs and analyzed with 3D OnDemand software. Measurements were recorded immediately postoperatively and at 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate dental implants with bone graft augmentation (deproteinized bovine bone) and Immediate dental implants without bone augmentation in people with Implant Therapy, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (Visual Analog Scale, VAS) (time frame: 1, 3, and 7 days postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.